Tokyo, Dec. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059937) titled 'Research study on changes in blood sugar levels, weight, and body fat due to mulberry green juice' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Other

Condition: Condition - Target condition (Condition) Healthy subjects and pre-symptomatic subjects (pre-metabolic syndrome, subjects with high blood glucose levels) Classification by specialty Internal Medicine (Metabolism / Endocrinology) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to exploratorily evaluate the effects of 4-week continuous intake of "Tenku Kuwa Aojiru" (Mulberry Green Juice) on biomarkers related to metabolic syndrome and diabetes (specifically postprandial blood glucose), as well as body weight and body fat percentage. Focusing on the effect of iminosugars, a component unique to mulberry leaves, to moderate sugar absorption, this pilot study verifies its usefulness in healthy individuals and those in the borderline range. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consumption of the test food "Tenku Kuwa Aojiru" (3g/pack) once daily for 4 weeks.

Eligibility: Age-lower limit - 20 years-old = Gender - Male Key inclusion criteria - Males and females in their 20s to 70s Subjects who understand the purpose and content of this study and provide written informed consent (Blood glucose group only) Subjects capable of participating in blood sampling at the designated location (Body weight group only) Subjects capable of measuring and recording body weight and body fat percentage at home Key exclusion criteria - Subjects with a history of serious diseases such as kidney disease Subjects taking medications or supplements unsuitable for the study Subjects who are pregnant, lactating, or possibly pregnant Subjects with an allergy to mulberry leaves Subjects currently receiving treatment for diabetes (insulin injections or oral hypoglycemic agents) Other subjects deemed inappropriate by the principal investigator Target Size - 110

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 15 Day Date of IRB - 2025 Year 11 Month 21 Day Anticipated trial start date - 2025 Year 11 Month 21 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068546

Disclaimer: Curated by HT Syndication.